EUROPEAN COMMISSION ISSUES MARKETING AUTHORIZATION FOR PREOTACT
NPS Pharmaceuticals and its partner Nycomed have announced that the European Commission has granted marketing authorization for Preotact (parathyroid hormone for injection) based on the outcome of recent Phase III studies.
Preotact is recombinant human parathyroid hormone. NPS has studied the drug in a number of clinical settings to document its safety and effects on bone. A pivotal Phase III study, known as TOP (Treatment of Osteoporosis with PTH), was a multicenter, randomized, double-blind and placebo-controlled clinical trial designed to evaluate the potential of PTH to reduce the risk of first and subsequent vertebral fractures in post-menopausal women.